Pm Surveillance Engineer I or Ii
hace 2 semanas
At MicroPort Orthopedics, we are never standing still. We know that knee and hip implants are constantly being improved just as medical procedures themselves evolve with each passing day. We not only embrace this constant advance in medicine. We celebrate it in our work. We operate with the heart of a start-up but the soul of an industry powerhouse. This is critical to achieving our goal of being the fastest-growing, innovation-driven company in orthopedics. Our top priority isn’t just to help surgeons get patients back on their feet. We want to help patients get back to Full Function, Faster. Come be a part of the journey
**Principal Responsibilities**
- Conducting all necessary Post-Market Surveillance (PMS) activities in accordance with the MPO procedures, European Medical Device Directive/Regulation, and the US FDA requirements. This will include but is not limited to the following: analysis of product complaints and determination of complaint trends; review and analysis of international registries and governmental databases; summary of conducted literature reviews; summary of MPO-sponsored clinical research, a summary of collected feedback from all sources, such as media, salesforce, and competitors’ websites.
- Scheduling and facilitating PMS review team meetings and writing and distributing meeting minutes. A person in this position will be responsible for following up on the action assignments generated from these meetings to ensure their timely completion.
- Assisting the Regulatory Affairs group with new product submissions and license renewals by providing results from PMS review findings and answering questions from various government agencies.
- Providing support to Product Development Engineers in developing DFMEA and Risk Analysis plans for new products under development and will review and approve them. In addition, she/he may assist with conducting literature searches and MAUDE database searches for the initial Clinical Evaluation Report.
PRINCIPAL ACTIVITIES:
- Organize and conduct PMS meetings according to the established meeting schedule.
- Provide key analysis of product safety by preparing complaint rates´ and complaint trends’ reports.
- Conduct, search and review published information and provide summary reports on published clinical data for the MPO and competitive products. Assist in writing initial Clinical Evaluation reports.
- Review Device Registries and government databases for MPO and competitive products.
- Write and distribute summary PMS reports and update the electronic database.
- Routinely update CERs with new PMS data after each PMS review.
- Provide training on the Post Market Review procedure and database keeping to new employees.
- Work closely with the respective departments to identify and analyze trends arising from product complaints, clinical studies, competitive products, literature reviews, etc.
- Provide input into identifying failure modes and risk assessment for new products under development, review FMEA reports.
- Analyze, interpret, and disseminate results from clinical studies.
- Create and update Clinical Evaluation Plans (CEPs), Summary of Safety and Clinical Performance (SSCP), and Periodic Safety Update Reports (PSURs).
- **
Other Duties** Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
**Skills Requirements**
- Must be familiar with basic orthopedic knowledge (i.e. anatomy, diseases of joints, the science of joint replacement, etc.) in order to read and comprehend published scientific literature.
- Must possess strong leadership skills and excellent analytical and problem-solving abilities.
- Good communication skills and technical writing skills are a must.
- Entry-level with a strong engineering background and independent research skills will also be considered.
- Must work well within a team environment.
- Must have the ability to balance multiple ongoing projects, timelines, and outputs.
**Experience Requirements**
- PMS Engineer I:_ Minimum 1 year of related experience required, including a combination of internship and/or research experience. Some experience in the medical device industry with a focus on clinical research, quality, reliability, or development engineering is preferred.
- PMS Engineer II:_ Minimum 3 years of related experience required, including a combination of internship and/or research experience. Some experience in the medical device industry with a focus on clinical research, quality, reliability or development engineering is preferred.
**Education Requirements**
Bachelor’s Degree in a Science/Engineering/Technical or related degree required; Master's Degree preferred. Education should include courses in design, material science, statistical analysis, and technical writing.
**_
-
Pm Surveillance Engineer I Or Ii
hace 2 semanas
San José, San José, Costa Rica Microport Orthopedics S.A. A tiempo completoAt MicroPort Orthopedics, we are never standing still.We know that knee and hip implants are constantly being improved just as medical procedures themselves evolve with each passing day.We not only embrace this constant advance in medicine.We celebrate it in our work.We operate with the heart of a start-up but the soul of an industry powerhouse.This is...
-
Pm Surveillance Engineer I
hace 2 semanas
San José, San José, Costa Rica Microport Orthopedics S.A. A tiempo completoAt MicroPort Orthopedics, we are never standing still.We know that knee and hip implants are constantly being improved just as medical procedures themselves evolve with each passing day.We not only embrace this constant advance in medicine.We celebrate it in our work.We operate with the heart of a start-up but the soul of an industry powerhouse.This is...
-
Engineer Ii, Quality
hace 4 días
San Francisco, Heredia, Costa Rica Boston Scientific Corporation A tiempo completo**Engineer II, Quality**:- Remote Eligible: Hybrid- Onsite Location(s): Heredia, H, CR**Additional Locations**: Costa Rica-Heredia**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance**At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing...
-
Engineering Manager for Post-Market Surveillance
hace 3 días
San Francisco, Heredia, Costa Rica Boston Scientific Corporation A tiempo completoJob DescriptionThe Quality Engineer II will be responsible for identifying and helping with continuous improvement projects related to product performance and the post market support processes.This role will involve acting as a team member in analyzing customer complaints, compliance events, clinical data and post marketing surveillance data by examining for...
-
Biomedical Engineer II
hace 3 días
San Francisco, Heredia, Costa Rica Boston Scientific Corporation A tiempo completoAbout the OpportunityBoston Scientific Corporation is seeking a Biomedical Engineer II - Quality to join their team. In this role, you will have the opportunity to work on post-market surveillance and design control activities.You will be responsible for executing Post Market Reporting assessments, identifying and analyzing trends in product performance, and...
-
Campaigner - Surveillance
hace 4 semanas
San José, Costa Rica Access Now A tiempo completo**The Organization and Role** * About Access Now* Access Now is a growing international human rights organization dedicated to defending and extending the digital rights of users at risk around the world, including issues of privacy, security, freedom of expression, and transparency. Our policy, advocacy, technology, and operations teams have staff...
-
Surveillance Advocate
hace 2 semanas
San José, San José, Costa Rica Access Now A tiempo completoAbout the RoleThe Surveillance Campaigner is a key member of Access Now's global team, responsible for leading the organization's campaign efforts in the fight against rights-abusing surveillance laws, technologies, and practices. This role requires a deep understanding of the challenges faced by at-risk and marginalized communities and the ability to...
-
Engineer I, Quality
hace 4 días
San Francisco, Heredia, Costa Rica Boston Scientific Corporation A tiempo completo**Engineer I, Quality**:- Remote Eligible: Hybrid- Onsite Location(s): Heredia, H, CR**Additional Locations**: N/A**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - High Performance**At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing...
-
Design Assurance Engineer II
hace 1 semana
San Francisco, Heredia, Costa Rica Boston Scientific A tiempo completoJob DescriptionThis Design Assurance Engineer II role involves providing Design Assurance Engineering support to Arden Hills and Heredia for commercial products in the market, ensuring delivery of the highest quality results to customers while supporting continuous improvement projects and quality initiatives.The ideal candidate will partner with Research &...
-
Compliance Risk Surveillance Analyst
hace 2 semanas
San Francisco, Heredia, Costa Rica Citi A tiempo completoCiti is a leading global bank seeking a skilled Compliance Risk Surveillance Analyst to join its Independent Compliance Risk Management (ICRM) team. As a key member of the Surveillance team, you will play a critical role in designing, implementing, and overseeing a suite of surveillances aimed at detecting behaviors that may violate regulatory rules or...
-
Medical Surveillance Specialist
hace 12 horas
San José, San José, Costa Rica Pfizer A tiempo completoJob SummaryWe are seeking a skilled Medical Surveillance Specialist to join our team. The successful candidate will be responsible for monitoring drug, biologics and medical devices surveillance programs.The ideal candidate will have a strong background in pharmacovigilance and safety data analysis. They will also possess excellent organizational skills,...
-
Regulatory Surveillance Analyst
hace 1 día
San Francisco, Heredia, Costa Rica Citi A tiempo completoAbout the RoleThis Compliance Surveillance Intmd Analyst position plays a critical role in ensuring the Firm's compliance with regulatory requirements and maintaining a culture of integrity. The ideal candidate will have a strong understanding of Compliance laws, rules, and regulations, as well as excellent communication and analytical skills.Key...
-
Compliance Surveillance Intmd Analyst
hace 2 días
San Francisco, Heredia, Costa Rica Citi A tiempo completoServes as a compliance risk analyst for Independent Compliance Risk Management (ICRM)'s CRM team responsible for the design, implementation, and oversight for a suite of control suites designed to detect behaviors that may violate regulatory rules or internal policies and procedures.When potentially anomalous behavior is detected, the team is responsible for...
-
Surveillance Portfolio Specialist
hace 2 semanas
San Francisco, Heredia, Costa Rica Citi A tiempo completoAs a Surveillance Portfolio Specialist, you will play a key role in designing, implementing, and overseeing surveillances to detect potential compliance risks.Key ResponsibilitiesCollaborate with team members to review and analyze surveillance alerts and reports.Analyze trade data to inform the Firm's response to regulatory inquiries.Develop and implement...
-
Senior Compliance Associate
hace 4 semanas
San José, Costa Rica Moody's Investors Service A tiempo completoPerform continuous testing and examinations of ratings processes for compliance with internal policies and procedures. - Assist in the preparation of periodic and ad hoc compliance reports outlining the results of Compliance’s Surveillance program. - Work with the Compliance Surveillance Team to enhance the Surveillance Program and improve existing...
-
Senior Compliance Associate
hace 17 horas
San José, Costa Rica Moody's Investors Service A tiempo completoPerform continuous testing and examinations of ratings processes for compliance with internal policies and procedures. - Assist in the preparation of periodic and ad hoc compliance reports outlining the results of Compliance’s Surveillance program. - Work with the Compliance Surveillance Team to enhance the Surveillance Program and improve existing...
-
Quality Assurance Specialist
hace 3 días
San Francisco, Heredia, Costa Rica Boston Scientific Corporation A tiempo completoAbout the RoleThe Biomedical Engineer II - Quality will be primarily focused on executing Post Market Reporting assessments (Periodic Safety Update Reports) including but not limited to all associated design control and quality system deliverables related with execution.This role identifies, analyzes, investigates, monitors, and documents trends at a product...
-
Post-market Surveillance Engineer I
hace 2 semanas
San José, Costa Rica MicroPort Orthopedics S.A. A tiempo completoAt MicroPort Orthopedics, we are never standing still. We know that knee and hip implants are constantly being improved just as medical procedures themselves evolve with each passing day. We not only embrace this constant advance in medicine. We celebrate it in our work. We operate with the heart of a start-up but the soul of an industry powerhouse. This is...
-
Software QA Engineer II
hace 4 horas
San Francisco, Heredia, Costa Rica Experian A tiempo completoAbout the RoleThis Software QA Engineer II - Automation position requires a strong background in test automation development, experience working in Agile environments, and expertise in cross-browser testing. The ideal candidate will have 2-4 years of QA Engineering experience, a BS or MS degree (or equivalent experience), and experience with Atlassian...
-
Quality Engineer Ii
hace 4 semanas
San José, Costa Rica Imprivata A tiempo completoCome join a winning team! Here at Imprivata, you’ll see a dedicated group of professionals who care about improving healthcare. Our team thrives on collaboration and sharing ideas, whether in a cross-functional meeting or at one of our virtual team-building events. While we're diverse in our backgrounds and skills, we have much in common. A passion for...